Tarceva

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.; Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.; Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.; Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg.

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Erlotinib hydrochloride 27.32 mg (equivalent to erlotinib 25 mg.)

Dosage:

25 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode yellow S-1-22970 Opadry white Y-5-7068 Sodium laurilsulfate Sodium starch glycolate Active: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25 mg. Excipient: Hyprolose Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose Opadry white Y-5-7068 Sodium laurilsulfate Sodium starch glycolate Titanium dioxide

Units in package:

Blister pack, PVC/Al foil, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

F Hoffmann-La Roche Ltd

Therapeutic indications:

· Tarceva is indicated for the first-line and maintenance treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. · Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who have previously received chemotherapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al foil - 30 tablets - 48 months from date of manufacture stored at or below 30°C

Authorization date:

2004-11-09

Patient Information leaflet

Tarceva

CMI 180220
1
TARCEVA
®
_FILM-COATED TABLETS _
pronounced "tar-see-va"
_contains the active ingredient erlotinib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tarceva tablets. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tarceva
tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TARCEVA IS USED
FOR
Tarceva contains the active
ingredient erlotinib.
Tarceva is used for the treatment of
non-small cell lung cancer (NSCLC).
It can be given before or after initial
chemotherapy if your cancer has
specific mutations in a protein called
epidermal growth factor receptor
(EGFR). It can also be given later on
when initial chemotherapy has not
worked.
Tarceva is also used in combination
with gemcitabine for the treatment of
pancreatic cancer.
Tarceva belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) agents which are used to
treat cancer.
Tarceva prevents the activity of the
EGFR protein. This protein is known
to be involved in the growth and
spread of cancer cells.
Your doctor may have prescribed
Tarceva for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TARCEVA HAS
BEEN PRESCRIBED FOR YOU.
Tarceva is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
TARCEVA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TARCEVA IF:
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO ERLOTINIB OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or other parts of the body

rash, itching or hives on the skin
2.
THE PACKAGE IS TORN

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Tarceva 220719
1
1.
PRODUCT NAME
Tarceva 25 mg, 100 mg, and 150 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tarceva film coated tablets are available in 3 dosage strengths
containing erlotinib
hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib.
Excipients with known effect
Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tarceva 25 mg tablets are round, biconvex, white to yellowish tablets
marked with
_T 25 _
engraved on one side.
Tarceva 100 mg film-coated tablets are round, biconvex, white to
yellowish tablets marked
with
_T 100 _
engraved on one side.
Tarceva 150 mg film-coated tablets are round, biconvex, white to
yellowish tablets marked
with
_T 150 _
engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
Tarceva is indicated for the first-line and maintenance treatment of
patients with advanced
(Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer
(NSCLC) with activating
EGFR mutations.
Tarceva is also indicated for the treatment of patients with locally
advanced or metastatic
NSCLC who have previously received chemotherapy.
PANCREATIC CANCER
Tarceva in combination with gemcitabine is indicated for the treatment
of patients with
locally advanced, unresectable or metastatic pancreatic cancer.
4.2
DOSE AND METHOD OF ADMINISTRATION
NON-SMALL CELL LUNG CANCER
NEW ZEALAND DATA SHEET
Tarceva 220719
2
It is recommended that EGFR mutation testing should be performed prior
to initiation of
Tarceva therapy in chemo-naive patients with advanced or metastatic
NSCLC. A well-
validated and robust test for activating EGFR mutations should be
used.
The recommended daily dose of Tarceva is 150 mg taken at least one
hour before or two
hours after the ingestion of food.
PANCREATIC